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FDA Takes Actions to Prevent Drug Shortages
FDA releases a strategic plan and issues a proposed notification rule to improve prevention and resolution of drug shortage problems.
AstraZeneca Receives Mixed Decision on US Patent Litigation
A US court of appeals rules on patent litigation for AstraZeneca's asthma drug Pulmicort Respules (budesonide).
Dow Chemical and Cambrex Complete Facility for Drug-Solubility Solutions
Dow Chemical and Cambrex open a new facility for Dow?s hydroxypropyl methylcellulose acetate succinate (HPMCAS).
WuXi PharmaTech Completes Cell Culture Capacity Expansion
WuXi PharmaTech has completed a cell culture capacity expansion, including two 2000 L disposable bioreactors.
Novartis Files Petition with FDA to Maintain Naming Policy for All Biologics
Novartis files Citizen Petition with FDA to maintain naming policy for all biologics to help ensure patient safety.
Novozymes Biopharma Collaborates with Almac in Drug Manufacture, Half Life Extension and Targeting Technologies
Combined service offers drug development companies efficiencies in time and resource.
GSK, Gates Foundation Seek Heat-Stable Adjuvants for Vaccines
GSK and the Gates Foundation will invest a combined $1.8 million in early stage research into vaccine thermostability.
Cobra Biologics Expands GMP Production Capacity
Cobra Biologics installs a new single-use bioreactor to expand its antibody GMP production capacity.
Thomas Engineering Names New Director of European Operations
Thomas Engineering names David Decker as the new director of European operations.
FDA Approves Extended-Release, Single-Entity Hydrocodone Product
Zhoydro ER is the first drug to have updated labeling now required for all ER/LA opioid analgesics.
ISPE Will Discuss Breakthrough Therapies at 2013 ISPE Annual Meeting
ISPE will discuss FDA’s recent draft guidance on breakthrough therapies at its 2013 Annual Meeting.
PharmaCell to Become European CMO for Dendreon
PharmaCell will become the European CMO for Dendreon for the commercial production of its cellular immunotherapy product Provenge.
Gentium Receives Marketing Authorization for Defitelio
Gentium receives marketing authorization for Defitelio (R) for the treatment of severe hepatic veno-occlusive disease.
Ganymed's IMAB362 Receives Orphan Drug Designation From FDA and EMA
Ganymed Pharmaceuticals receives orphan drug designation from FDA and EMA for IMAB362 for the treatment of pancreatic cancer.
CDER Director Proposes Reclassification of Opioid Products
CDER recommends reclassifying opioid products as Schedule II.
IDT Biologika and Oncotec Pharma Produktion Announce Expansion Projects
IDT Biologika and Oncotec Pharma Produktion to expand vaccine and oncology capacity.
SGS Life Science Services Opens Center of Excellence for Biophysical Analysis
SGS Life Science Services opens a Center of Excellence for Biophysical Analysis in the UK.
CPhI Announces CPhI Pharma Award Winners
CPhI recognizes innovation in formulation, process development, and packaging.
India Sets Pharma Export Growth Targets
IBEF and Pharmexcil report the country?s plans for growth and its commitment to lowering the cost of medicines globally.
Excipients and Formulation Development at Focus at CPhI
Recent news and developments from CPhI of excipient producers, CDMOs, and CMOs are highlighted.
Tracking the Market for APIs and Intermediates
Fine-chemical producers and contract API manufacturers expand capacity and expand service offerings.
Global Outlook for Excipients Bodes Well
Excipients market will be shaped by greater supply-chain concerns, quality-by-design programs,and overall drug-safety issues.
A Strong Outlook for Global Pharma Outsourcing
Overall growth in the market for pharmaceutical contract research and manufacturing is strong although growth in established markets erodes at the expense of emerging markets.
Solving the Insoluble
PharmTech spoke with Dow about innovations in polymers to address poor solubility.
Beckman Coulter, Hach Company Combine Particle Characterization and Counting Businesses
Beckman Coulter Life Sciences combines its particle characterization business with the Hach Company particle counting business.
Novartis, Amgen, and Bristol-Myers Squibb Report Sales Up in Third Quarter
Big pharma companies Novartis, Amgen, and Bristol-Myers Squibb announce positive third-quarter 2013 results.
Amarin Cuts Staff Following FDA Vote
Amarin cuts staff in half after an FDA committee rejects its product label expansion.
Pliva Opens New Oral Solid Forms Facility
Pliva?s new Oral Solid Forms Facility will increase Pliva's production capacities for tablets and capsules.
Self-Sealing Thermoplastic Elastomer Solution for Infusion Therapy Systems
Pharmaceutical Technology speaks with PolyOne, a provider of specialized polymer materials, services and solutions about the company?s product, Versaflex HC, for infusion therapy stoppers and septums.
Cambridge Major Laboratories Discusses Strategy on its Merger with AAIPharma Services
Brian Scanlan, CEO and president of Cambridge Major Laboratories, discusses the rationale behind the company's merger with AAIPharma Services.
